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HIVNCT03086655

Tel-Me-Box: Testing a New, Real-time Strategies for Monitoring HIV Medication Adherence in India

A study testing Tel-me-box with reminder features and Tel-me-box in people with HIV and Medication Adherence, run by University of California, San Francisco at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Currently available methods to monitor antiretroviral (ARV) adherence to HIV treatment and prevention, such as self-report, pill counts, medication electronic monitoring system (MEMS), and devices which wirelessly monitor adherence in real-time, have multiple limitations, including over-reporting, inability to assess… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, Medication Adherence
What is being tested?
Tel-me-box with reminder features and Tel-me-box
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
1 siteIndia
Study dates
13 Aug 2021to 11 Jan 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV-positive
  • Currently on antiretroviral therapy (ART)
  • Speaks one of the local languages
  • Able and willing to participate in the study, provide informed consent, contact information, and express a willingness to return for follow-up visits every three months for 12 months after baseline.
  • Adherence-challenged per self-report, i.e. report of <90% ART adherence or >2 ART treatment interruptions of at least 2 days in the past 3 months

Who cannot join

  • Unwilling or unable to participate in the study and/or return for follow-up appointments
  • younger than 18 years old
  • Not HIV-infected
  • Not currently on ART
  • Does not speak one of the local languages

Trial locations and contacts

1 site in 1 country.

India1 site

  • St. John & Research Institute/St John & Medical College & Hospital

    Bangalore, Karnataka

Other trials in India

About this study

Official title: Tel-Me-Box: Validating and Testing a Novel, Low-cost, Real-time Monitoring Device With Hair Level Analysis Among Adherence-challenged Patients

Currently available methods to monitor antiretroviral (ARV) adherence to HIV treatment and prevention, such as self-report, pill counts, medication electronic monitoring system (MEMS), and devices which wirelessly monitor adherence in real-time, have multiple limitations, including over-reporting, inability to assess pill ingestion, and size/expense. Our multidisciplinary research team at the University of California, San Francisco (UCSF) and in India has designed a new adherence-monitoring device called "Tel-Me-Box" which is small, low-cost, rechargeable, inconspicuous, and could be programmed to deliver tailored real-time adherence reminders following additional hardware modifications. The aim of this study is to modify and validate this discreet Tel-Me-Box (TMB) adherence monitoring and reminder device against hair ARV concentrations as a pharmacologic measure of drug ingestion/adherence, a measure pioneered and validated by our team, with the expectation that this device and intermittent hair monitoring could have widespread utility for HIV and non-HIV adherence science, both in India and globally.

Read the detailed description

Novel, validated methods to monitor adherence to HIV treatment in real time are urgently needed given the well-known limitations of self-reported adherence, pill counts, and MEMS caps. In order to be scalable and sustainable in both resource-rich and resource limited settings, such devices need to be low-cost and designed in a way that does not increase the risk of accidental HIV disclosure and subsequent stigma. Devices which both monitor adherence in real time and provide tailored reminders to patients for medication-taking have the potential to greatly improve adherence to HIV treatment as well as to treatment for other chronic diseases. Our Indo-US collaborative team has been conducting research on HIV stigma, ARV adherence patterns and barriers, treatment outcome, and drug resistance for over a decade. The study investigators have also pioneered the use of ARV concentrations in small hair samples to measure long-term ARV adherence in resource-rich and limited settings (RLS). In response to the need for novel adherence measures, our team has recently developed Tel-Me-Box, a small, low-cost adherence device that monitors adherence in real time, by transmitting a wireless signal to a server when opened. The investigators now propose to add hardware that will enable the server software to wirelessly program the device to activate tailored medication-taking reminders (via a beep, vibration, or LED light) after a period of inactivity. The device fits in a pocket, can hold 1-2 weeks' worth of medications, has a long battery life, simple charging capability, and has been found acceptable to Indian patients with adherence challenges in pilot studies. Since HIV stigma serves as a profound barrier to ARV adherence in many settings, including India, the small, inconspicuous nature of Tel-Me-Box, along with its ability to deliver tailored reminder features honors participants' privacy concerns. Since this electronic device monitoring cannot assess actual drug ingestion, validating it against a biological measure of adherence, such as ARV hair concentrations, is crucial.

This study includes a pilot randomized control trial (RCT) to examine acceptability and feasibility and to estimate the effect size of automated tailored real-time adherence reminders on hair ARV concentrations, device- monitored adherence, and viral load suppression in adherence-challenged patients.

The aim of this study is to validate TMB as an innovative tool to assess adherence and predict treatment outcomes, and demonstrate the feasibility of hair analyses in RLS. If successful, pilot data will be available on the efficacy of the Tel-Me-Box automated, tailored reminders for a future large scale RCT.

Being tested
Tel-me-box with reminder features, Tel-me-box
Keywords
biological markers, monitoring device, wireless technology
Medical subject headings
Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tel-me-box with reminder featuresBehavioural

    Participants will meet with a study staff member to go over their daily routines, including their pill taking schedule, and to work out a plan for tailored reminders. The participant will choose from the reminders available and convey their preferences regarding when reminders should be sent for the TMB. Preferences will be stored in an online secure database. If requested by the participant, the reminder schedule and type of reminder can be reprogrammed by study staff via an online portal. When the reminder is reprogrammed the TMB receives a new configuration SMS to update the device reminder settings.

  • Tel-me-boxBehavioural

    Participants receive tel-me-box device with no reminder features added.

Study groups in NCT03086655
Study groupRoleWhat they receive
Pillbox ('Tel-me-box') with reminder featuresExperimentalParticipants randomly assigned to the intervention reminder condition will choose from the reminders available and convey their preferences regarding when reminders should be sent for the tel-me-box device.
Receives: Behavioral: Tel-me-box with reminder features
Pillbox ('Tel-me-box') without reminder featuresOtherThe control arm will include tel-me-box monitoring only. No reminder features will be included with the device.
Receives: Behavioral: Tel-me-box

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tel-me-box Adherence

    Number of days over past 30 days with at least one device-recorded pill box opening.

    Measured: 30 days prior to each follow-up assessment (3, 6, 9 and 12 months post baseline).

  2. HIV Viral Load (VL)

    HIV viral load (number of copies/ml of blood), dichotomized as undetectable VL (= suppressed, meaning <50 copies/ml detected) vs. detectable (or unsuppressed, meaning >= 50 copies/ml detected)

    Measured: Baseline, and 6 and 12 month follow-up

  3. Hair Concentrations of Anti-retroviral Medications (ARV), in ng/mg

    Hair concentrations of Efavirenz (EFV) or Dolutegravir (DTG) in ng/mg, and log transformed to improve normality of the distribution if necessary. The vast majority of participants were on an ARV regimen that included either EFV or DTG at the time of the study.

    Measured: 12 month follow-up

Secondary outcomes (1)

  1. Self-reported Adherence in the Past Month

    Participant self-report measured using the visual analogue scale to assess percent of pills taken in the past month, further dichotomized into optimal (100%) vs. suboptimal adherence (<100%)

    Measured: 30 days prior to baseline and 3, 6, 9, and 12 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2017
  2. Study start13 Aug 2021
  3. Primary completion11 Jan 2023
  4. Study completion11 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03086655
Sponsor's protocol ID
R01MH109310
Other IDs
R01MH109310
Status last verified
Aug 2025
First submitted
16 Mar 2017
Last updated
22 Aug 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Farmer KC. Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice. Clin Ther. 1999 Jun;21(6):1074-90; discussion 1073. doi: 10.1016/S0149-2918(99)80026-5.

    PubMed 10440628

  • Chesney MA. The elusive gold standard. Future perspectives for HIV adherence assessment and intervention. J Acquir Immune Defic Syndr. 2006 Dec 1;43 Suppl 1:S149-55. doi: 10.1097/01.qai.0000243112.91293.26.

    PubMed 17133199

  • Berg KM, Arnsten JH. Practical and conceptual challenges in measuring antiretroviral adherence. J Acquir Immune Defic Syndr. 2006 Dec 1;43 Suppl 1(Suppl 1):S79-87. doi: 10.1097/01.qai.0000248337.97814.66.

    PubMed 17133207

  • Kripalani S, Yao X, Haynes RB. Interventions to enhance medication adherence in chronic medical conditions: a systematic review. Arch Intern Med. 2007 Mar 26;167(6):540-50. doi: 10.1001/archinte.167.6.540.

    PubMed 17389285

  • Nair BG, Newman SF, Peterson GN, Wu WY, Schwid HA. Feedback mechanisms including real-time electronic alerts to achieve near 100% timely prophylactic antibiotic administration in surgical cases. Anesth Analg. 2010 Nov;111(5):1293-300. doi: 10.1213/ANE.0b013e3181f46d89. Epub 2010 Sep 14.

    PubMed 20841414

  • Patel UB, Ni Q, Clayton C, Lam P, Parks J. An attempt to improve antipsychotic medication adherence by feedback of medication possession ratio scores to prescribers. Popul Health Manag. 2010 Oct;13(5):269-74. doi: 10.1089/pop.2009.0053.

    PubMed 20879908

  • Ruppar TM. Randomized pilot study of a behavioral feedback intervention to improve medication adherence in older adults with hypertension. J Cardiovasc Nurs. 2010 Nov-Dec;25(6):470-9. doi: 10.1097/JCN.0b013e3181d5f9c5.

    PubMed 20856132

  • Burgess SW, Sly PD, Devadason SG. Providing feedback on adherence increases use of preventive medication by asthmatic children. J Asthma. 2010 Mar;47(2):198-201. doi: 10.3109/02770900903483840.

    PubMed 20170329

  • Sabin LL, DeSilva MB, Hamer DH, Xu K, Zhang J, Li T, Wilson IB, Gill CJ. Using electronic drug monitor feedback to improve adherence to antiretroviral therapy among HIV-positive patients in China. AIDS Behav. 2010 Jun;14(3):580-9. doi: 10.1007/s10461-009-9615-1.

    PubMed 19771504

  • Cramer J, Rosenheck R, Kirk G, Krol W, Krystal J; VA Naltrexone Study Group 425. Medication compliance feedback and monitoring in a clinical trial: predictors and outcomes. Value Health. 2003 Sep-Oct;6(5):566-73. doi: 10.1046/j.1524-4733.2003.65269.x.

    PubMed 14627063

  • de Bruin M, Hospers HJ, van Breukelen GJ, Kok G, Koevoets WM, Prins JM. Electronic monitoring-based counseling to enhance adherence among HIV-infected patients: a randomized controlled trial. Health Psychol. 2010 Jul;29(4):421-8. doi: 10.1037/a0020335.

    PubMed 20658830

  • Vallabhaneni S, Chandy S, Heylen E, Ekstrand ML. Evaluation of WHO immunologic criteria for treatment failure: implications for detection of virologic failure, evolution of drug resistance and choice of second-line therapy in India. J Int AIDS Soc. 2013 Jun 3;16(1):18449. doi: 10.7448/IAS.16.1.18449.

    PubMed 23735817

  • Bachman Desilva M, Gifford AL, Keyi X, Li Z, Feng C, Brooks M, Harrold M, Yueying H, Gill CJ, Wubin X, Vian T, Haberer J, Bangsberg D, Sabin L. Feasibility and Acceptability of a Real-Time Adherence Device among HIV-Positive IDU Patients in China. AIDS Res Treat. 2013;2013:957862. doi: 10.1155/2013/957862. Epub 2013 Jul 16.

    PubMed 23956851

  • Vallabhaneni S, Chandy S, Heylen E, Ekstrand M. Reasons for and correlates of antiretroviral treatment interruptions in a cohort of patients from public and private clinics in southern India. AIDS Care. 2012;24(6):687-94. doi: 10.1080/09540121.2011.630370. Epub 2011 Nov 22.

    PubMed 22107044

  • Steward WT, Herek GM, Ramakrishna J, Bharat S, Chandy S, Wrubel J, Ekstrand ML. HIV-related stigma: adapting a theoretical framework for use in India. Soc Sci Med. 2008 Oct;67(8):1225-35. doi: 10.1016/j.socscimed.2008.05.032. Epub 2008 Jul 1.

    PubMed 18599171

Questions about this trial

What is this clinical trial studying?

A study testing Tel-me-box with reminder features and Tel-me-box in people with HIV and Medication Adherence, run by University of California, San Francisco at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tel-me-box Adherence (time frame: 30 days prior to each follow-up assessment (3, 6, 9 and 12 months post baseline).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03086655, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

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